Prescription drug · ANDA
Pacerone (Amiodarone hydrochloride) NDC 71610-787
Amiodarone hydrochloride 200 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-787-30 | 7161007873071610078730 | 30 TABLET in 1 BOTTLE (71610-787-30)Marketed from Jan 25, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Pacerone
- Generic name (nonproprietary)
- amiodarone hydrochloride
- Active ingredients
- Amiodarone hydrochloride — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075135
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-787_f373ed89-c786-4f7c-a55e-2d1dc62971b0SPL ID f373ed89-c786-4f7c-a55e-2d1dc62971b0SPL set ID 02f4a736-63ed-4ad4-a1f1-b21a71e928bdRxCUI 833528, 834346UNII 976728SY6Z
- Pharmacologic class
- Antiarrhythmic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471610078730followed by a unit qualifier and the quantityPackage 71610-0787-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Pacerone is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71610-787
- What is NDC 71610-787?
- 71610-787 is the product NDC for Pacerone (amiodarone hydrochloride), Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pacerone (Amiodarone Hydrochloride).
- What is the active ingredient?
- Amiodarone hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pacerone?
- 4 other product NDCs are listed under this name. See all Pacerone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pacerone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paceroneamiodarone hydrochloride | Amiodarone hydrochloride 400 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-1645 | 00245-1645-0100245-1645-30 |
| Paceroneamiodarone hydrochloride | Amiodarone hydrochloride 100 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0144 | 00245-0144-0100245-0144-1100245-0144-30 |
| Paceroneamiodarone hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0147 | 00245-0147-0100245-0147-1500245-0147-60+1 more |
| Paceroneamiodarone hydrochloride | Amiodarone hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2148 | 72162-2148-03 |
Other NDCs under ANDA 075135
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Paceroneamiodarone hydrochloride | Amiodarone hydrochloride 100 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0144 |
| Paceroneamiodarone hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0147 |
| Paceroneamiodarone hydrochloride | Amiodarone hydrochloride 400 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-1645 |
| Paceroneamiodarone hydrochloride | Amiodarone hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2148 |